Prescription drug · ANDA
Bupivacaine Hydrochloride NDC 76420-008
Bupivacaine hydrochloride 5 mg/mL · Injection, Solution · Epidural, Intracaudal · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-008-10 | 76420000810 | 10 mL in 1 VIAL, SINGLE-DOSE (76420-008-10)Marketed from Jan 16, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bupivacaine Hydrochloride
- Generic name (nonproprietary)
- bupivacaine hydrochloride
- Active ingredients
- Bupivacaine hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Intracaudal
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203895
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 76420-008_ead08199-44c1-c795-e053-2995a90a7e08SPL ID ead08199-44c1-c795-e053-2995a90a7e08SPL set ID a60303c2-5217-41db-855b-83fa2a749da2RxCUI 1724880UNII 7TQO7W3VT8
- Pharmacologic class
- Amide Local Anesthetic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N476420000810followed by a unit qualifier and the quantityPackage 76420-0008-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Bupivacaine hydrochloride injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of bupivacaine hydrochloride injection, USP in these patients. Bupivacaine hydrochloride injection, USP is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS . The routes of administration and in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203895
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal | Eugia US LLC | 55150-167 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | Eugia US LLC | 55150-171 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal | Eugia US LLC | 55150-168 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal | Eugia US LLC | 55150-169 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Intracaudal | Eugia US LLC | 55150-170 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Retrobulbar | Eugia US LLC | 55150-172 |
| Bupivacaine Hydrochloride | Bupivacaine hydrochloride 2.5 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal | Asclemed USA, Inc. | 76420-018 |